Australia

Legal Status

Therapeutic goods for human use which are imported or manufactured in Australia must be included in the Australian Register of Therapeutic Goods, in accordance with the Therapeutic Goods Act 1989. Traditional medicines also need registration. Alternative medicines are allowed to enter this register at a lower level than many other pharmaceuticals. In some cases, e.g., substances about which there are safety concerns, or products which are claimed to treat more serious medical conditions, a higher level of a pre-market registration will be required. The Traditional Medicines Evaluation Committee (TMEC) was established to provide expertise for the evaluation of non-prescription traditional medicines and to give advice to the authority on their registration. The TMEC is appointed by the Minister and consists of six to nine members who are experts in: the clinical practice or teaching of alternative medicine; pharmacy with expertise in pharmacognosy or plant toxicology; the manufacture of alternative medicines; or who are medical practitioners or who have qualifications and experience in clinical pharmacology [125].

According to general requirements for labels of medicines, herbs are included in the List of Australian Approved Names for Pharmaceutical Substances which is published by the Therapeutic Goods Administration in its edition "TGA Approved Terminology for Drugs" dated January 1993, with amendments. There are also special regulations on the expression of quantity or proportion of active ingredients in drug products, with special requirements for herbal ingredients [126].